TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI) has filed a preliminary Investigational New Drug (pre-IND) application with the U.S. Food and Drug Administration (FDA) for Revimmune™ in the treatment of refractory Multiple Sclerosis (MS). The Company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase 3 clinical trial involving approximately 270 patients with relapsing/remitting MS with a primary endpoint of improvement in function (reversal of disability). Unlike Revimmune, no other approved therapy for MS has shown a recovery of neurologic function and all others have been approved on the more limited basis of reducing the risk of disease exacerbation or progression. Accentia’s proposal to use the restoration of neurologic function as the endpoint will be the first filed with the FDA.
